Delays in study startup and patient enrollment are major contributors to cost overruns in clinical trials. A properly designed and executed feasibility study can provide a comprehensive assessment of a clinical trial’s specific challenges, as well as strategies to mitigate risks before startup activities begin.
Biopharmaceutical companies that utilize feasibility studies experience faster clinical trial accrual and significantly fewer delays in enrollment than those that forgo the assessment.
PPD works directly with clients to design a feasibility study that is tailored to the needs of the planned clinical trial or program. During the design phase of the study, clients interact with our feasibility and therapeutic area specialists to ensure that all relevant needs for the trial or program are considered. Key components of PPD’s strategic feasibility assessment that guide site selection and recruitment planning include:
- Evaluation of the available population of patients likely to meet all major entry criteria of a trial
- Assessment of patient and physician willingness to participate in the study
- Evaluation of current patterns of care in patients and the acceptability of the protocol design
- Evaluation of the competitive environment for a study
- Assessment of regulatory and institutional review board/ethics committee (IRB/EC) timelines and potential challenges
In addition, by aligning protocol and trial optimization and investigator validation services under our strategic feasibility group, PPD is able to provide a single point of accountability for achieving study startup targets for each project, improving alignment and collaboration with functional groups who contribute to the site selection pathway.
PPD’s protocol optimization group works with clients to design an effective protocol to achieve the drug development targets and control costs.
PPD’s trial optimization services range from a basic trial review and risk assessment to a fully enhanced trial optimization assessment.
PPD works directly with clients to design a feasibility study that is tailored to the needs of the planned clinical trial or program.